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MD4563C1 - Co-micronisation product comprising ulipristal acetate - Google Patents

Co-micronisation product comprising ulipristal acetate

Info

Publication number
MD4563C1
MD4563C1 MDA20150053A MD20150053A MD4563C1 MD 4563 C1 MD4563 C1 MD 4563C1 MD A20150053 A MDA20150053 A MD A20150053A MD 20150053 A MD20150053 A MD 20150053A MD 4563 C1 MD4563 C1 MD 4563C1
Authority
MD
Moldova
Prior art keywords
ulipristal acetate
micronisation
product
micronisation product
relates
Prior art date
Application number
MDA20150053A
Other languages
Romanian (ro)
Russian (ru)
Other versions
MD4563B1 (en
MD20150053A2 (en
Inventor
Флориан Баттюн
Пьер-Ив Жувен
Жером Эк
Оде Колен
Original Assignee
Laboratoire Hra-Pharma
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Laboratoire Hra-Pharma filed Critical Laboratoire Hra-Pharma
Publication of MD20150053A2 publication Critical patent/MD20150053A2/en
Publication of MD4563B1 publication Critical patent/MD4563B1/en
Publication of MD4563C1 publication Critical patent/MD4563C1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/18Feminine contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Endocrinology (AREA)
  • Biophysics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Reproductive Health (AREA)
  • Gynecology & Obstetrics (AREA)
  • Diabetes (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Steroid Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Circuit Arrangements For Discharge Lamps (AREA)
  • Emergency Protection Circuit Devices (AREA)
  • Thyristors (AREA)

Abstract

The invention relates to a co-micronisation product comprising an active ingredient selected from the group consisting of ulipristal acetate, a metabolite of ulipristal acetate and mixtures thereof, and a pharmaceutically acceptable solid surfactant selected from C8-C20 alkyl sulphate salts and combinations thereof.The invention also relates to a method for preparing the co-micronisation product, to a pharmaceutical composition comprising said co-micronisation product and to the use thereof as a contraceptive and in treating or preventing gynecological disorders.
MDA20150053A 2012-11-08 2013-11-07 Co-micronisation product comprising ulipristal acetate MD4563C1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1260603A FR2997627B1 (en) 2012-11-08 2012-11-08 CO-MICRONIZATION PRODUCT COMPRISING ULIPRISTAL ACETATE
PCT/FR2013/052670 WO2014072646A1 (en) 2012-11-08 2013-11-07 Co-micronisation product comprising ulipristal acetate

Publications (3)

Publication Number Publication Date
MD20150053A2 MD20150053A2 (en) 2015-10-31
MD4563B1 MD4563B1 (en) 2018-05-31
MD4563C1 true MD4563C1 (en) 2018-12-31

Family

ID=47878175

Family Applications (1)

Application Number Title Priority Date Filing Date
MDA20150053A MD4563C1 (en) 2012-11-08 2013-11-07 Co-micronisation product comprising ulipristal acetate

Country Status (30)

Country Link
US (2) US9610293B2 (en)
EP (1) EP2916871B1 (en)
JP (1) JP2015536968A (en)
KR (1) KR20150093170A (en)
CN (1) CN104902928B (en)
AR (1) AR093402A1 (en)
AU (1) AU2013343320B2 (en)
BR (1) BR112015010271B1 (en)
CA (1) CA2890272A1 (en)
CR (1) CR20150297A (en)
CY (1) CY1119542T1 (en)
DK (1) DK2916871T3 (en)
EA (1) EA027641B1 (en)
EC (1) ECSP15022442A (en)
ES (1) ES2606307T3 (en)
FR (1) FR2997627B1 (en)
GE (1) GEP201706637B (en)
HR (1) HRP20161624T1 (en)
HU (1) HUE031911T2 (en)
LT (1) LT2916871T (en)
MD (1) MD4563C1 (en)
MX (1) MX363699B (en)
PL (1) PL2916871T3 (en)
PT (1) PT2916871T (en)
RS (1) RS55429B1 (en)
SI (1) SI2916871T1 (en)
SM (1) SMT201600445B (en)
TW (1) TWI617325B (en)
UA (1) UA117465C2 (en)
WO (1) WO2014072646A1 (en)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2997627B1 (en) * 2012-11-08 2015-01-16 Hra Pharma Lab CO-MICRONIZATION PRODUCT COMPRISING ULIPRISTAL ACETATE
CN103923154B (en) * 2013-01-16 2017-09-26 杭州容立医药科技有限公司 The eutectic and preparation method of CDB-2914
CN105663140A (en) * 2014-11-21 2016-06-15 四川海思科制药有限公司 Pharmaceutical composition containing ulipristal acetate and preparation method of pharmaceutical composition
CN104865215A (en) * 2015-05-16 2015-08-26 南京海纳医药科技有限公司 Ulipristal acetate tablet and method for determining dissolution of ulipristal acetate tablet
CN105919150A (en) * 2016-05-12 2016-09-07 高洁珺 Method for replacing chemical additives in tabletting process
CN106265533A (en) * 2016-10-10 2017-01-04 朱隆娅 A kind of Adprin granule and preparation method thereof
FR3060389B1 (en) 2016-12-20 2019-05-31 Laboratoire Hra-Pharma ENROBE COMPRISING COMPRISING ULIPRISTAL ACETATE OR ONE OF ITS METABOLITES

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2627696B1 (en) 1988-02-26 1991-09-13 Fournier Innovation Synergie NEW GALENIC FORM OF FENOFIBRATE
US4954490A (en) * 1988-06-23 1990-09-04 Research Triangle Institute 11 β-substituted progesterone analogs
GB9608719D0 (en) 1996-04-26 1996-07-03 Scherer Ltd R P Pharmaceutical compositions
FR2757397B1 (en) * 1996-12-23 1999-03-05 Mazal Pharma PHARMACEUTICAL COMPOSITION BASED ON RHEIN OR DIACERHEIN WITH IMPROVED BIOAVAILABILITY
IL127129A (en) * 1998-11-18 2004-06-01 Ferring Bv Method for preparation of progesterone tablets for vaginal delivery and tablets so prepared
FR2821555B1 (en) * 2001-03-01 2003-05-16 Besins Int Lab PROGESTIVE CO-MICRONIZED WITH A SURFACTANT, PHARMACEUTICAL COMPOSITION COMPRISING SAME, METHODS OF MAKING SAME AND USES THEREOF
FR2841138B1 (en) * 2002-06-25 2005-02-25 Cll Pharma SOLID PHARMACEUTICAL COMPOSITION COMPRISING A LIPOPHILIC ACTIVE INGREDIENT, ITS PREPARATION PROCESS
ES2212912B1 (en) 2003-01-22 2005-10-01 Crystal Pharma, S.A. PROCEDURE FOR OBTAINING 17ALFA-ACETOXI-11BETA- (4-N, N-DIMETHYLAMINEPHENYL) -19-NORPREGNA-4,9-DIEN-3,20-DIONA.
CA2573266C (en) 2004-07-09 2011-11-08 The Population Council, Inc. Sustained release compositions containing progesterone receptor modulators
WO2008037044A1 (en) 2006-09-27 2008-04-03 Medley S.A. Indústria Farmacêutica Oxcarbazepine-containing oral formulation and a process to obtain the same
JP5649305B2 (en) 2006-12-20 2015-01-07 テバ ウィメンズ ヘルス インコーポレイテッド Orally disintegrating solid dosage form containing progestin and method for producing and using the same
AU2007339820A1 (en) * 2006-12-28 2008-07-10 Repros Therapeutics Inc. Methods and formulations for improved bioavailability of antiprogestins
WO2009067557A1 (en) * 2007-11-19 2009-05-28 Teva Pharmaceutical Industries Ltd. Deferasirox pharmaceutical compositions
US8299050B2 (en) 2008-01-29 2012-10-30 Laboratoire Hra-Pharma Method for treating uterine fibroids
US8512745B2 (en) * 2008-12-08 2013-08-20 Laboratoire Hra Pharma Ulipristal acetate tablets
PL2419108T3 (en) 2009-04-14 2017-08-31 Laboratoire Hra Pharma Method for on-demand contraception
EP2471537A1 (en) * 2010-12-30 2012-07-04 PregLem S.A. Treatment of pain associated with dislocation of basal endometrium
FR2997627B1 (en) * 2012-11-08 2015-01-16 Hra Pharma Lab CO-MICRONIZATION PRODUCT COMPRISING ULIPRISTAL ACETATE

Also Published As

Publication number Publication date
CR20150297A (en) 2015-08-14
RS55429B1 (en) 2017-04-28
MX363699B (en) 2019-03-28
TWI617325B (en) 2018-03-11
US20170157146A1 (en) 2017-06-08
BR112015010271B1 (en) 2020-04-22
WO2014072646A1 (en) 2014-05-15
EP2916871A1 (en) 2015-09-16
EP2916871B1 (en) 2016-09-14
JP2015536968A (en) 2015-12-24
BR112015010271A2 (en) 2017-07-11
AR093402A1 (en) 2015-06-03
DK2916871T3 (en) 2017-01-02
AU2013343320A1 (en) 2015-06-04
GEP201706637B (en) 2017-03-10
LT2916871T (en) 2016-12-27
EA201500513A1 (en) 2015-08-31
CN104902928B (en) 2018-10-23
HRP20161624T1 (en) 2017-01-27
SI2916871T1 (en) 2017-03-31
CY1119542T1 (en) 2018-03-07
PL2916871T3 (en) 2017-02-28
HUE031911T2 (en) 2017-08-28
MD4563B1 (en) 2018-05-31
MX2015005762A (en) 2016-02-11
EA027641B1 (en) 2017-08-31
CN104902928A (en) 2015-09-09
MD20150053A2 (en) 2015-10-31
UA117465C2 (en) 2018-08-10
CA2890272A1 (en) 2014-05-15
PT2916871T (en) 2016-12-15
AU2013343320B2 (en) 2018-03-08
BR112015010271A8 (en) 2019-10-01
FR2997627A1 (en) 2014-05-09
SMT201600445B (en) 2017-01-10
ES2606307T3 (en) 2017-03-23
TW201427718A (en) 2014-07-16
US20150290218A1 (en) 2015-10-15
ECSP15022442A (en) 2016-01-29
US9610293B2 (en) 2017-04-04
FR2997627B1 (en) 2015-01-16
KR20150093170A (en) 2015-08-17

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Legal Events

Date Code Title Description
FG4A Patent for invention issued
KA4A Patent for invention lapsed due to non-payment of fees (with right of restoration)
MM4A Patent for invention definitely lapsed due to non-payment of fees